Recall Z-1776-2022
Paragon 28, Inc. · initiated July 13, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Codes / lots: UDI-DI: 00889795114228, Lot: 5007499
Reason for recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
FDA-determined cause: Device Design
Action taken
On 7/13/22, recall notices were emailed to distributors who were asked to do the following: 1) Review physical inventory of product within your control and at a hospital/health care facility within your region. Any affected product that is identified is to be discontinued, quarantined and not distributed any further. 2) Return affected devices to the recalling firm. 3) Complete and return the Recall Response form. For inquiries, contact the recalling firm at mkinnee@paragon28.com
Details
- Recall number
- Z-1776-2022
- Initiated
- July 13, 2022
- Posted by FDA
- September 22, 2022
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 145
- Distribution
- US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
- Recalling firm
- Paragon 28, Inc., Englewood, CO